Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
GLICLAZIDE
Servier Laboratories (Ireland) Ltd
80 Milligram
Tablets
1976-01-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamicron 80mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80mg gliclazide. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, circular, flat, bevel-edged, cross scored compressed tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of diabetes mellitus of the maturity onset type, which is not adequately controlled by dietary means, and does not require insulin therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults only_: The final dosage regimen depends upon the individual requirements of the patient and is at the discretion of the physician. The dose will be generally between 80 and 320 mg daily. Biguanide hypoglycaemic agents may be added to the regimen if required. 4.3 CONTRAINDICATIONS o known hypsersensitivity to gliclazide or to any of the excipients, other sulphonylureas, sulphonamides, o type 1 diabetes, o diabetic pre-coma and coma, diabetic keto-acidosis, o severe renal or hepatic insufficiency: in these cases the use of insulin is recommended. o Treatment with miconazole _(see Section “Interactions with other medicinal products and other forms of_ _interaction”),_ o Pregnancy and lactation _(see Section “Pregnancy and Lactation”)._ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE HYPOGLYCAEMIA: This treatment should be prescribed only if the patient is likely to have a regular food intake (including breakfast). It is important to have a regular carbohydrate intake due to the increased risk of hypoglycaemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Hypoglycaemia is more likely to occur during loc-calorie diets, following prolonged or strenuous exercise, alcoho Přečtěte si celý dokument